FDA Adverse Event
Malfunction
Summary report: N
HS III PROXIMAL SEAL SYTEM 4.3MM
MDR report key: 3101428
·
Received May 3, 2013
Report
- Report Number
- 2242352-2013-00431
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE RING AROUND THE HEARTSTRING III AORTIC CUTTER WAS ABNORMALLY CURVED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195041 | HS III PROXIMAL SEAL SYTEM 4.3MM | CLAMPLESS BEATING HEART | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3043 | 25057051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |